Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double‐blinded crossover study

Chen, J.-W.; Lauritzen, Torsten; Christiansen, JS; Jensen, Lisbeth Bjerring; Clausen, Wan Hui Ong; Christiansen, Jens Sandahl

doi:10.1111/j.1464-5491.2004.01404.x

Cited by 15 publications

(18 citation statements)

References 26 publications

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“…The data came from a previously published study of a biphasic insulin aspart (IAsp) preparation [5]. The complete 24-h serum insulin concentrations measured in the 20 type 1 diabetes subjects, who were given three daily s.c. injections at different sites within the abdominal region, are presented in Fig.…”

Section: Methodsmentioning

confidence: 99%

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Within-patient variation of the pharmacokinetics of subcutaneously injected biphasic insulin aspart as assessed by compartmental modelling

2006

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Population estimates of the chosen model show that intra-subject variations between injections is of the same order of magnitude as inter-subject variation, partially explaining the difficulties encountered when individually tailoring intensified insulin therapy. We conclude that the explicit consideration of a rather simple kinetic model will allow better experimental designs in the future study of s.c. insulin preparations.

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Section: Methodsmentioning

confidence: 99%

“…Acknowledgements The authors are grateful to J. S. Christiansen and J.-W. Chen for carrying out the clinical trial [5] that allowed us to perform this research. This research was supported by The Danish Ministry of Science, Technology and Innovation, and Novo Nordisk.…”

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confidence: 99%

Within-patient variation of the pharmacokinetics of subcutaneously injected biphasic insulin aspart as assessed by compartmental modelling

2006

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“…An earlier and less comprehensive double‐blind crossover study of 26 patients with type 1 diabetes found insulin C max values were approximately twice as high after all three main meals during thrice‐daily BIAsp 70 treatment than during thrice‐daily BIAsp 30 treatment (figure 2) [24]. Furthermore, the time to C max ( t max ) was significantly shorter (p < 0.05) after all three meals with BIAsp 70: 60 min for all three meals compared with 90, 75 and 82.5 min for breakfast, lunch and dinner, respectively, for BIAsp 30 [24]. As in the Heise et al .…”

Section: Pharmacology Of Mid‐ and High‐ratio Premix Insulin Analoguesmentioning

confidence: 98%

Mid‐ and high‐ratio premix insulin analogues: potential treatment options for patients with type 2 diabetes in need of greater postprandial blood glucose control

Christiansen

Liebl²,

Davidson

et al. 2009

Diabetes Obesity Metabolism

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Some patients with type 2 diabetes continue to have high postprandial blood glucose levels on twice-daily regimens of 'low-ratio' premix insulin formulations (up to 30% rapid-acting, with 70% protracted insulin). These patients require intensified insulin therapy, which can be provided by a twice- or thrice-daily regimen of mid-ratio (50% rapid-acting and 50% protaminated intermediate-acting insulin - human or analogue) or high-ratio (70% rapid-acting and 30% protaminated insulin - analogue only) premix insulin. Alternatively, a third daily injection of low-ratio premix insulin can be added to the regimen, with the option of incorporating one or more injections of mid- or high-ratio premix as required, and as an alternative to basal-bolus therapy. How these mid- and high-ratio formulations differ from the low-ratio premix insulins is reviewed here, with the aim of identifying the role of these formulations in diabetes management. Glucose clamp studies have shown that premix analogues give serum insulin levels proportional to their percentage of rapid-acting uncomplexed insulin: the higher the proportion, the greater the maximum level reached. Other pharmacokinetic parameters were not always significantly different between the mid- and high-ratio formulations. In clinical trials, postprandial plasma glucose and glycated haemoglobin A1c (HbA(1c)) levels were significantly reduced with thrice-daily mid- /high-ratio premix analogue when compared with twice-daily low-ratio biphasic human insulin (BHI) 30/70 or once-daily insulin glargine. Moreover, glycaemic control with mid-/high-ratio premix analogue was found to be similar to that with a basal-bolus therapy. Mid- and high-ratio premix regimens are generally well tolerated. The frequency of minor hypoglycaemia was reportedly higher with mid- /high-ratio premix analogues than with BHI 30, but nocturnal hypoglycaemia was less frequent. Although there is little evidence that clinical outcomes with mid-ratio premix analogues are different from those with high-ratio, they are useful additions to the low-ratio formulations for the management of diabetes, and addressing postprandial hyperglycaemia in particular.

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“…AUC 6–14 h was markedly lower for BIAsp 70 than for BIAsp 30 (BIAsp 30/BIAsp 70 = 1.9; 95% CI [1.42, 2.55]; P <0.002). [13] The time to maximum insulin concentration ( T max ) was significantly shorter after all three meals with BIAsp 70 ( P <0.05). Peak levels for both BIAsp 30 and BIAsp 70 were seen to increase with each daily injection over this 15-day period, suggesting a degree of accumulation that needs to be taken into consideration if a TID dose is to be prescribed.…”

Section: Clinical Evidence For Mid-/high-ratio Premix Analogs For Intmentioning

confidence: 99%

“…Peak levels for both BIAsp 30 and BIAsp 70 were seen to increase with each daily injection over this 15-day period, suggesting a degree of accumulation that needs to be taken into consideration if a TID dose is to be prescribed. [13]…”

Section: Clinical Evidence For Mid-/high-ratio Premix Analogs For Intmentioning

confidence: 99%

Intensifying existing premix therapy (BIAsp 30) with BIAsp 50 and BIAsp 70: A consensus statement

Brito

Ligthelm

Boemi

et al. 2011

Indian J Endocr Metab

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In 2009, consensus guidelines were published on intensification of insulin therapy using the premix analog biphasic insulin aspart (BIAsp) 30 in the treatment of type 2 diabetes, based on the recommendations of an international, independent expert panel. The guidelines included recommendations and titration algorithms for intensification from basal insulin once (OD) or twice daily (BID) to BIAsp 30 BID, from OD BIAsp 30 to BID, and from BID BIAsp 30 to three times daily (TID). Building on these recommendations, the objective was to develop similar, simple and effective guidelines for intensification switch from a BIAsp 30 to a mid-/high-ratio premix regimen for the vast majority of patients with type 2 diabetes. A panel of independent experts with extensive clinical experience in premix analog therapy met in October 2009 to review the therapeutic role of mid- and high-ratio premixes (BIAsp 50 and 70, respectively). The panel outlined a series of algorithms for intensifying BIAsp 30 BID and TID with mid-/high-ratio premixes, along with practical suggestions relating to intensification for individual patients. A simple tool to aid dose adjustment was also developed. The guidelines suggested here should assist physicians in introducing mid-/high-ratio premixes to optimize the insulin therapy of patients with type 2 diabetes who are failing to achieve glycemic targets on a BIAsp 30 BID or TID regimen.

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Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double‐blinded crossover study

Cited by 15 publications

References 26 publications

Within-patient variation of the pharmacokinetics of subcutaneously injected biphasic insulin aspart as assessed by compartmental modelling

Within-patient variation of the pharmacokinetics of subcutaneously injected biphasic insulin aspart as assessed by compartmental modelling

Mid‐ and high‐ratio premix insulin analogues: potential treatment options for patients with type 2 diabetes in need of greater postprandial blood glucose control

Intensifying existing premix therapy (BIAsp 30) with BIAsp 50 and BIAsp 70: A consensus statement

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